Senior Manager - New Product Introduction (all genders)
Senior Manager - New Product Introduction (NPI) (all genders)
Just-Evotec Biologics is seeking a highly motivated Senior Manager - New Product Introduction (NPI) to join a fast-paced, collaborative, and multidisciplinary team to lead activities related to the introduction of new products to the J.POD Toulouse biotherapeutics manufacturing facility. The role will provide cross-functional leadership for all phases of Just-Evotec’s NPI process – stretching from project initiation through to process validation and registration activities.
The role will require close collaboration with all functional areas of the J.POD Toulouse team – including Product and Process Design, Process Engineering, Process Automation, Facilities Engineering, Validation, Quality Controls, Quality Assurance, Supply Chain, Manufacturing, Digital and EHS. The role will participate in client facing meetings to discuss topics related to NPI activities. The role will also collaborate with Just-Evotec Global MSAT, Client Program Managers, Global Supply Chain for client projects and continuous improvement efforts.
Reporting to the Site Head for MSAT, you have responsibility to develop the NPI team, including recruiting and employee development.
Lead stakeholders to implement the NPI process at J.POD Toulouse to support the start and rapid scale-up of commercial GMP manufacturing activities.
Partner with Product and Process Design to coordinate successful efficient scale-up and transfer operations and to ensure the successful integration of process knowledge into manufacturing operations.
Partner with supply chain to support Bill of Material development and demand planning for new products.
Partner with Engineering and Digital disciplines to conduct facility fit assessments and plans to support system updates needed for new product introduction.
Partner with Manufacturing to develop high-quality batch records, robust processes and innovative technology solutions for new product introduction.
Partner with Quality, Validation and Global MSAT to develop and implement process validation and comparability study activities leading to successful product registration.
Acting as a subject matter expert for regulatory and client inspection audits.
Partner with Business Development, Supply Chain, and Manufacturing to support the Sales and Operation (S&OP) process.
Utilize the team’s technical skills and process knowledge to participate and/or lead investigations related to NPI activities. Collaborate with impacted groups to develop and execute effective CAPA.
Apply Operational Excellence principles to lead continuous improvement in NPI activities.
Actively mentor and develop team members.
Ph.D. (or Masters) degree in relevant field or related program with 10+ (15+) years of pharmaceutical/biotech validation experience including a minimum of 3-5 years of experience leading a New Product Introduction program for biopharmaceutical products.
Extensive knowledge and experience with late-stage clinical and commercial biologics drug substance manufacturing programs, including project leadership roles in process validation, PPQ, and commercial manufacturing.
Proven record of accomplishment and self-directed leadership in GMP pharmaceutical or biotechnology is required.
Technical mastery of cell culture, purification, and solution preparation operations using disposable-based manufacturing technologies
Demonstrated leadership capabilities to build and mentor high-performing teams, drive change, and influence internal and external stakeholders
Extensive knowledge of US FDA CFRs and European EMA, including ICH guidelines, as they relate to drug substance biological manufacturing
Good interpersonal, team, and collaborative skills are required.
Excellent verbal and written communication skills in French and English; ability to interface with all levels of the organization
Additional Preferred Qualifications:
Experience in audits and inspections by health authorities, clients and other external auditors as a presenter or audit support staff.
Experience in leading risk assessment and risk management for pharmaceutical products and processes. Experience in applying principles of Quality by Design.
Experience in developing submission packages for pharmaceutical product registration
Experience in client relations and communications.
Demonstrated success in leading multi-disciplinary teams that span multiple organizations
Entrepreneurial drive to achieve business objectives.
About Just – Evotec Biologics
Just – Evotec Biologics, wholly-owned by Evotec SE, is a unique platform company that integrates the design, engineering, development, and manufacture of biologics. With deep experience in the fields of protein, process, and manufacturing sciences, the Just team came together to solve the scientific and technical hurdles that block access to life-changing protein therapeutics; from the design of therapeutic molecules to the design of the manufacturing plants used to produce them.
Just's focus is to create access and value for a global market through scientific and technological innovation. Our state-of-the-art labs and cGMP clinical manufacturing plant are currently co-located in Seattle's South Lake Union neighborhood - the center of Seattle's medical, global health, and technology industries and a noted top emerging life science hub in the U.S. Our fast-growing team of 300 employees is expanding Just's innovative platform and footprint - Opening our first North American J.POD® commercial manufacturing facility in the Seattle area and building our second European J.POD commercial manufacturing facility in the Toulouse France area. For job opportunities, learn more at www.just.bio/careers
FR : Dans le cadre de sa politique Diversité, Evotec étudie, à compétences égales, toutes les candidatures dont celles des personnes en situation de handicap.
ENG : In the frame of our Diversity policy, Evotec considers, with equal competences, all applications including people with disabilities.